1 qa violations a look at the first 3 years.... 2 qa-preparing the facilities remembering the...
TRANSCRIPT
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QA Violations
A Look at the First
3 Years...
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QA-Preparing the FacilitiesRemembering the Beginnings-
Subchapter 22 Quality Assurance Regs
Workshops provided QA education
Over 1500 registrants in attendance
Compliance Guidance Documents
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QA Findings Year 1
Inspectors--inspection review to ensure QA program started.
--Medical Physicist QC Survey completed
--QA Manual completed
--Initial QC tests completed
--Processor QC started
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QA Findings Year 2
AHA! . . . QA Program and QC testing . . . here to stay!
Some registrants stored, disposed of units Inspectors checking QC reports thoroughly
Annual Medical Physicist QC Survey - - - actually meant ANNUAL!
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QA Findings Year 3
Continue to perform thorough reviews during inspection
Registrants still not performing all QC tests at specified time intervals
Repeat Violations result in monetary penalty assessments
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TRENDS
What types of violations
are we seeing?
How do they impact the work of the QA Medical Physicist?
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QC VIOLATIONS
What 5 violations do you think
are the MOST POPULAR?
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1st Most Popular QC Violation
Missing QC Test Items - Rad 46%
Year 1 2 3 Total
# Violations 741 819 512 2072
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2nd Most Popular QC Violation
No annual Medical Phys. QC Survey - Rad 18%
Year 1 2 3 Total
# Violations 346 239 240 825
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3rd Most Popular QC Violation
No or Incomplete QA Manual 11%
Year 1 2 3 Total
# Violations 323 104 82 509
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4th Most Popular QC Violation
No QA Program 8%
Year 1 2 3Total
# Violations 345 11 20 376
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5th Most Popular QC Violation
Processing Film when QC Test Failed 7%
Year 1 2 3 Total
# Violations 123 90 102 315
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Total QA Violations by Year
2001
1581
1272
0
300
600
900
1200
1500
1800
2100
Year 1 Year 2 Year 3
Num
ber Q
A Vi
olatio
ns
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Violation Documents Annually
636 619488
376
182104 110 132
1231
0200400600800100012001400
Year 1 Year 2 Year 3
Num
ber V
iola
tion
docu
men
ts
(NOV)(AO)(NOP)
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Penalties Issued Annually
$109,900
$128,300$133,400
$0
$20,000
$40,000
$60,000
$80,000
$100,000
$120,000
$140,000
$160,000
Year 1 Year 2 Year 3
Pe
na
ltie
s Is
sue
d
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Medical Physicists’ Role
How do these violations
impact the work
of the QA Medical Physicist?
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QA Violations & Medical Physicists
Medical Physicist’s Annual QC Survey
MP review all the periodic QC tests - done and reported properly
If test items are missing - must be noted on the annual QC Survey
If items are missing, the facility FAILS in these items
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QA Violations & Medical PhysicistsMedical Physicist’s Annual QA
Program Review
MP review with the Registrant: QA program & QA Manual
Registrant must: document the periodic tests Table 1 throughout the year
See the FAQs for more information
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QA Violations & Medical PhysicistsDocumentation is very important!
When inspectors find QC test violations, sometimes the MP QC survey indicates the facility passed, some items not done.
Confusion for registrant.
The MP annual QA Review - facility missed some QC tests.
NOTE: ALL test result records MUST BE made available for review by the certified medical physicist and the state inspector.
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QA Goals
• Increase Registrant Compliance • BRH Inspector & Physicist
– communication– collaboration
• Educate Registrants – how to lower ESE– how to improve IQ
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Quality Assurance
THANK YOU!
GRACIAS!
MERCI BEAUCOUP!